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Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) (VADT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00032487
First Posted: March 22, 2002
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Eye Institute (NEI)
SmithKline Beecham
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin
Drug: Glimepiride
Drug: Rosiglitazone
Drug: Metformin

  Participant Flow
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  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1/Standard Glycemic Control Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Arm 2/Intensive Glycemic Control Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
Total Total of all reporting groups

Baseline Measures
   Arm 1/Standard Glycemic Control   Arm 2/Intensive Glycemic Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 899   892   1791 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      606  67.4%      612  68.6%      1218  68.0% 
>=65 years      293  32.6%      280  31.4%      573  32.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 60.3  (9.0)   60.5  (9.0)   60.4  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      26   2.9%      26   2.9%      52   2.9% 
Male      873  97.1%      866  97.1%      1739  97.1% 
Region of Enrollment 
[Units: Participants]
 		     
United States   899   892   1791 


  Outcome Measures
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1.  Primary:   Primary Major Macrovascular Events   [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ]
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2.  Secondary:   Secondary Endpoint   [ Time Frame: Post baseline time to first event up to 82 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study had several limitations. Since we were studying veterans, the patients were predominantly men, and extrapolation of our findings to women must be done with caution.Changes in therapeutic agents have occurred since the design of our protocol


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